Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SYNCHRONIZER #208

K-Number: K810588 · 1981-04-10

ApplicantBrattle Instrument Corp.
Decision Date1981-04-10
Product CodeIXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNCHRONIZER #208 is the device name listed in this FDA 510(k) record. The listed applicant is Brattle Instrument Corp.. It received FDA 510(k) clearance on 1981-04-10 under 510(k) number K810588. The device is classified under product code IXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRONIZER #208?

SYNCHRONIZER #208 is a medical device that received FDA 510(k) clearance on 1981-04-10. The listed applicant is Brattle Instrument Corp.. The 510(k) number is K810588.

When did SYNCHRONIZER #208 receive FDA 510(k) clearance?

SYNCHRONIZER #208 received FDA 510(k) clearance on 1981-04-10, under 510(k) number K810588.

Who is the listed applicant for SYNCHRONIZER #208?

The FDA 510(k) record lists Brattle Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNCHRONIZER #208?

The FDA product code for SYNCHRONIZER #208 is IXO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Brattle Instrument Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K802978TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300K781681PHIPIOLOGICAL SYNCHRONIZER PART#205K770692MONITOR, FETAL, NO. L04-1100K770296FETAL MONITOR, PART #101-11009K770295ABDOMINAL ECG PROCESSOR FOR FETAL MONI.K770297FETAL MONITOR, PART #100-11009

View all 7 devices →

Related Devices (Code: IXO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K854976RMI RESPIRATORY GATING SYSTEM MODEL 301Radiation Measurements, Inc.K811587SIEMENS ANGIOTRONSiemens Corp.K791959POST EXTRA SYSTOLIC POSTENTLATORMedrad, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑